Hemostatic Procedure After Biopsy of the Cervix

Not Applicable

Completed

• Conditions: Uterine Cervical Dysplasia
• Interventions: Other: Wait and see; Procedure: Monsel´s Paste

• Registration Number: NCT02486471
• Lead Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Brief Summary

Cytological abnormalities of the Cervix uteri need to be clarified by colposcopy biopsy. To avoid bleeding after biopsy, monsel´s paste is a common used Agent. In a randomized clinical Trial the use of monsel´s paste after biopsy will be compared to no Intervention. The Primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of Independent factors such as Age and Body mass index.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-28
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Primary Completion: 2016-01
• Status Verified: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-13
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 166

Inclusion Criteria

• abnormal pap smear
• first colposcopy ever

Exclusion Criteria

• pregnancy
• bleeding disorder
• the use of blood thinner
• language barrier
• unwillingness to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Observational approach	Wait and see	Wait and see
Use of Monsel´s Paste	Monsel´s Paste	cervical coagulation using a hemostatic agents, ie monsel´s paste

Primary Outcome Measures

Name	Time	Method
Blood loss after 15 minutes (5-step visual analogue scale)	15 minutes	blood loss 15 minutes after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)

Secondary Outcome Measures

Name	Time	Method
Blood loss after 6 hours (5-step visual analogue scale)	6 hours	blood loss 6 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Blood loss after 24 hours (5-step visual analogue scale)	24 hours	blood loss 24 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Sensation of pain after 15 minutes (10-step visual analogue scale)	15 minutes	patients will score their pain Level using a 10-step visual analogue scale (VAS) 15 minutes after biopsy
Overall Sensation of pain after 24 hours (10-step visual analogue scale)	24 hours	patients will score their pain Level using a 10-step visual analogue scale (VAS) 24 hours after biopsy
Blood loss after 3 hours (5-step visual analogue scale)	3 hours	blood loss 3 hours after biopsy will be measured judging the amount of blood on the sanitary napkin (5-step visual analogue scale)
Overall Satisfaction of the Patient after 24 hours (10-step visual analogue scale)	24 hours	patients will score their satisfaction Level using a 10-step visual analogue scale (VAS)

Trial Locations

Locations (2)

Department of Obstetrics and Gynecology of the Ruhr University Bochum; 🇩🇪 Herne, NRW, Germany

Zydolab - Institute of Cytology and Immune Cytochemistry; 🇩🇪 Dortmund, NRW, Germany